Dynavax Reports on HEPLISAV(TM) Regulatory Path
The primary objectives of HBV-23 will be:
- To evaluate the overall safety of HEPLISAV with respect to clinically significant adverse events; and
- To demonstrate the noninferiority of the peak seroprotection rate (SPR) induced by HEPLISAV to Engerix-B in subjects with type 2 diabetes mellitus.
HBV-23 will include 5,500 HEPLISAV subjects and 2,500 Engerix-B subjects, randomized 2:1 and stratified by age and diabetes diagnosis. HEPLISAV subjects will receive two doses at 0 and 1 month, while Engerix-B subjects will receive three doses at 0, 1 and 6 months. All HEPLISAV subjects will be evaluated for safety for one year following the second dose and all potential autoimmune events will be adjudicated by a
"Following extensive discussion with
The 120-Day response will incorporate the target population for HEPLISAV and size of the safety database, and will address Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP)-related items, including questions arising from a recent EMA GCP inspection.
Engerix-B® is a registered trademark of GlaxoSmithKline.
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HEPLISAV is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
This press release contains "forward-looking" statements, including expectations for HEPLISAV, our discussions with the
Vice President and Chief Business Officer
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